Prevision Policy Clips | HHS Secretary Azar To Testify On President's Budget Thursday

MPS III Rare Disease Guidance From FDA Explicitly Seeks Patient-Caregiver Preferences In Endpoints; “Large Treatment Effect” Could Obviate Randomization

Prevision Policy Clips | Federal Register Unavailable Feb. 7

Part D “Specialty” Tier Overhaul: “Preferred-Specialty” Will Test Plans’ Ability To Get Rebates; Threshold Jumps To $780 Per Month

Barrier Riffs: House Pharmaceutical “Barriers” Hearing Focuses On Patient Assistance Programs, Overseas Tax Loopholes

FDA Biosimilar “Carve Out” Draft Guidance Reflects Established Precedents; Agency Promises Six-Month Reviews For 351(k) Supplements To Add Indications

FDA “Quality Maturity” Rating: Stakeholders Welcome Transparency But Raise Issues About International Inspection Disparity, Need For Product-Level Data

Prevision Policy Clips | Thursday, February 6, 2020

FDA Oncology “Project 2025” Initiative Will Kick Off With Disease Area Workshops This Year; OCE Showcases Ongoing Projects At Anniversary Event

Prevision Policy Clips | Trump Calls Out Grassley Drug Pricing Bill, No Mention Of International Reference Pricing

FDA Under Stephen Hahn: Commissioner Likely To Focus On Agency Operations, Not New Policy

Prevision Policy Clips | FDA Electronic Submissions and Data Standards Public Meeting

Helping Biosimilars Compete: FDA/FTC Statement Underscores Policy Goal – But Long Gestation Period Illustrates Bureaucratic Reality

ICER Framework Updates: Pilot Will Assess RWE For Accelerated Approval Drugs; Evidence Re-Evaluations After One Year for All Drugs

Prevision Policy Clips | Biosimilar Competition: FDA/FTC Workshop Announced, Along With Promotional Guidance

Diabetes Safety Standards Update Headlines CDER 2020 Guidance Agenda; Another Big Year Planned For Clinical/Medical Advice

Encouraging Expanded Access: FDA Disputes Arguments That Cost-Recovery Rules Are A Barrier

Prevision Policy Clips | CMS Proposes Changes To Co-Pay Coupons, Rebate Retention Policies In ACA

Advisory Committee Tracker: ODAC Is Back In February With Early Prostate Cancer Phototherapy – And Hard-To-Explain Lilly Lung Cancer Review

CMS Medicaid “Block Grant” Proposal Allows Formularies – But With Some “Protected” Classes

Prevision Policy Clips | Medicaid Overhaul Proposal Will Permit States To Use Restrictive Formularies

Risks Of Re-Opening Orphan Drug Act: Rep. Schrader Suggests Removing Cost Recovery Option During House Hearing On Technical Fix

ICER Migraine Cost-Effectiveness Review Uses Alternative Timepoint For Maximum Benefit; Allergan Collaboration Pays Off – And Brings Call For FDA Participation Going Forward

CAR-T Patient Travel Reimbursement Okayed By HHS Inspector General; Twist On Patient Support Program Reflects Unique Care Delivery Model

Part D-For-All? Medicare Drug Benefit Could Be A Point Of Departure If Political Dynamics Shift Toward Medicare For All